DE112008002454T5 - Device for treating a blood circulation device - Google Patents

Abstract

Apparatus (10; 120; 140; 150; 160; 180; 190; 210) for treating a blood circulation conduit (14), comprising:
- An implant (20) for placement in the conduit (14), which implant (20) comprises:
A tubular endoprosthesis (30) having an X-X 'axis including a latticework (36) radially deployable between a contracted position and an unfolded position, said latticework (36) having an outer surface (40), which is bounded by an axial edge (44);
At least one intermediate member (24) which is more flexible than the latticework (36), the flexible intermediate member (24) being movably formed on the endoprosthesis (30) for insertion between the outer surface (40) and the conduit (14) and
A tool (26) for deploying the implant (20), which tool has a configuration for inserting the implant (20) into the conduit (14) in which the tool (26) holds the latticework (36) in the collapsed position and a configuration, ...

Description

• – ein Implantat zum Implantieren der Leitung, welches Implantat umfasst: • eine röhrenförmige Endoprothese mit einer Achse, die ein Gitterwerk aufweist, das radial entfaltbar ist zwischen einer zusammengezogenen Stellung und einer gespreizten Stellung, welches Gitterwerk eine äußere Oberfläche aufweist, die axial durch einen axialen Rand begrenzt ist; • wenigstens ein Zwischenglied, das flexibler ist als das Gitterwerk, welches flexible Zwischenglied beweglich an der Endoprothese angebracht ist zur Einfügung zwischen der äußeren Oberfläche und der Leitung • ein Werkzeug zum Entfalten des Implantats, welches Werkzeug eine Stellung einnehmen kann, in der das Implantat in die Leitung eingefügt werden kann, in welchem Werkzeug das Gitterwerk in seiner zusammengelegten Stellung gehalten wird, und einer Stellung, in der das Implantat gelöst wird, in welcher das Gitterwerk die entfaltete Stellung einnimmt.

The present invention relates to a device for treating a blood circulation line, having the following features:

• An implant for implanting the lead comprising: a tubular endoprosthesis having an axis having a lattice radially unfoldable between a contracted position and a splayed position, said latticework having an outer surface axial through an axial surface Border is limited; At least one intermediate member which is more flexible than the latticework, which flexible intermediate member is movably attached to the endoprosthesis for insertion between the outer surface and the conduit; a tool for deploying the implant, which tool can assume a position in which the implant is in the conduit can be inserted, in which tool the latticework is held in its collapsed position, and a position in which the implant is released, in which the latticework occupies the unfolded position.

The Device is particularly applicable for the treatment of defective endogenous valves, such as heart valves or pulmonary valves.

The Heart has valves at the outlet of the right ventricle (lung valve) and on the left ventricle (aortic valve).

These Valves ensure that the blood flows in one direction flows and a reflux at the end of the ventricular Contraction is prevented.

Yet Diseases or malfunctions affect the correct function the valves.

Especially the valves are exposed to calcification, leaving a reflux or back pressure in the direction of the ventricle, which is the blood has expelled. The back pressure problem leads to an abnormal expansion of the ventricle, so it eventually can come to a failure of the heart.

to Surgical treatment of this type of disorder is implantation an endovil between the valves of the diseased body's own valve known. The endovalve has a tubular Endoprosthesis on, by a self-expanding tissue and a flexible closure or valve, usually made of animal tissue is formed. The flexible closure is permanently attached to the endoprosthesis.

These Type of endovalve can be implanted endoluminally, so that the risks associated with the implantation of the valve, in particular the risk of death, be significantly reduced.

In In some cases endoprostheses act after implantation not completely satisfactory. Although the outer one Peripheral surface of the endoprosthesis immediately against the seat rests in the endogenous valve, in which the Flaps between the seat and the outer peripheral surface The endoprosthesis can be flattened, but still leaks around the outer peripheral surface of the endoprosthesis remain around, especially at the joint between the flaps of the body's own valve. These leaks occur over 50% of patients who undergo such surgery were.

To overcome this problem, the arrangement of pontics of considerable radial thickness is known, in particular from US 2005/0137688 , For example, these intermediate links are attached directly to the outer peripheral surface of the endoprosthesis or formed from an outer flap that flips against the outer surface of the endoprosthesis.

such Intermediate links are deformable. They fill in the gaps, which can arise around the valve.

The However, intermediate links inserted around the endoprosthesis enlarge the radial dimensions of the Endovalve. The deployment tool used to implant the endovalves used has a radial dimension that is not negligible is and interferes with the implantation in the body can be.

It It is therefore an object of the invention to provide a treatment device create, which includes an implant that in dense state in a conduit of blood circulation with irregular Cross section can be inserted while the radial dimension when inserted into the body of the Patient is low.

The The invention therefore relates to a device of the above type, which is characterized in that in the configuration for the insertion, the flexible intermediate member at least one having free part axially spaced from the outer Surface held beyond the axial edge so that the radial dimension of the implant is minimized, while the free part at least partially against the outer Surface is displaceable when the tool of its configuration for insertion into its configuration moves to share.

• – das Zwischenglied weist wenigstens eine flexible, umlaufende Schürze auf, der mit einem Rand an der Endoprothese befestigt wird und einen freien Rand aufweist, wobei die Schürze zwischen einer Konfiguration mit reduzierter radialer Dimension, in der der freie Rand axial vom axialen Rand der äußeren Oberfläche gehalten wird und die Schürze die Einfügungsposition einnimmt und einer Konfiguration, die nach unten gegen die äußere Oberfläche geklappt ist und die die Schürze in der freigegebenen Position einnimmt;
• – das Zwischenglied weist wenigstens ein radiales Dichtkissen auf, das radial in Bezug auf die Schürze vorspringt;
• – die oder jedes Band, verbindet den freien Teil und das Entfaltungswerkzeug, wobei das oder jedes Betätigungsband axial beweglich ist in Bezug auf die Endoprothese und den freien Teil in Richtung der äußeren Oberfläche zieht, wenn das Entfaltungswerkzeug aus einer Konfiguration zum Einfügen in die Konfiguration zum Freigeben umgeschaltet wird;
• – das oder jedes Betätigungsband umfasst eine Verriegelungsschleife, wobei das Entfaltungswerkzeug einen Stift aufweist, der beweglich ist zwischen einer Eingriffsposition in der Verriegelungsschleife, in der die axiale Verschiebung des Verriegelungsbandes relativ zu der Endoprothese bewirkt, dass das freie Teil in Bezug auf die Endoprothese axial bewegt wird, und einer gelösten Position außerhalb der Verriegelungsschleife, in der die axiale Verschiebung des Verriegelungsschleife die gelöste Position des freien Teils bewirkt;
• – das Entfaltungswerkzeug umfasst eine Umhüllung zur Aufnahme des Implantats, wobei das Betätigungsband lösbar mit der Umhüllung verbunden ist, und die Verschiebung der Umhüllung fort von der Endoprothese bewirkt, dass der freie Teil gegen die Oberfläche durch Zug des Bandes bewegt wird;
• – das Entfaltungswerkzeug umfasst einen Stent zum Halten der Endoprothese in Axialrichtung vor der radialen Entfaltung des Gitterwerks, wobei das Betätigungsband in dem Stent gehalten ist und beweglich in Bezug auf die Endoprothese durch den Stent verbleibt, so dass es von dem entfernten Ende des Stents gezogen wird;
• – das flexible Zwischenglied ist spontan verformbar, wenn das Entfaltungswerkzeug aus seiner Stellung zum Einfügen in die Stellung zur Freigabe bewegt wird, so dass spontan bewirkt wird, dass der freie Teil wenigstens teilweise gegen die äußere Oberfläche gezogen wird;
• – das flexible Zwischenglied weist wenigstens ein elastisches Teil auf, das das freie Teil und die äußere Oberfläche verbindet, wobei das elastische Teil in einer insta bilen Position unter Spannung durch das Entfaltungswerkzeug in der Einfügungsposition gehalten wird;
• – das Gitterwerk weist eine innere Oberfläche auf, die eine zentrale Blutzirkulationsbahn begrenzt;
• – das Gitterwerk weist wenigstens ein Band zur Betätigung des Zwischengliedes auf, wobei das Betätigungsband wenigstens einen ersten Verbindungspunkt zum Zwischenglied und wenigstens einen zweiten und dritten Verbindungspunkt zum Gitterwerk aufweist, wobei der zweite und dritte Verbindungspunkt im Winkel zueinander in Bezug auf das Gitterwerk um dessen Achse versetzt sind;
• – die Bewegung des Gitterwerks der Endoprothese zwischen der zusammengezogenen Stellung und der entfalteten Stellung bewirkt, dass der Abstand, der den zweiten Verbindungspunkt und den dritten Verbindungspunkt trennt, vergrößert wird, und die axiale Verschiebung des ersten Verbindungspunktes zwischen einer Position axial im Abstand von dem zweiten und dritten Verbindungspunkt und einer Position axial näher an dem zweiten und dritten Punkt verschoben wird, in der der erste Verbindungspunkt gegenüber der äußeren Oberfläche liegt.

The device according to the invention can ei one or more of the following characteristics, on their own or in any technically possible combination:

• - The intermediate member has at least one flexible, circumferential skirt, which is fastened with an edge to the endoprosthesis and having a free edge, wherein the skirt between a configuration of reduced radial dimension, in which the free edge axially from the axial edge of the outer surface is held and the skirt occupies the insertion position and a configuration that is folded down against the outer surface and occupies the skirt in the released position;
• - The intermediate member has at least one radial sealing pad which projects radially with respect to the skirt;
• The or each strap connects the free part and the deployment tool, the or each actuation strap being axially movable with respect to the endoprosthesis and the free part towards the outer surface as the deployment tool moves from a configuration for insertion into the configuration Share is switched;
• The or each actuation strap comprises a locking loop, the deployment tool having a pin movable between an engagement position in the locking loop in which the axial displacement of the locking strap relative to the endoprosthesis causes the free part to move axially with respect to the endoprosthesis and a disengaged position outside the locking loop, in which the axial displacement of the locking loop causes the disengaged position of the free part;
• The deployment tool comprises a sheath for receiving the implant, the operating band being releasably connected to the sheath, and the displacement of the sheath away from the endoprosthesis causes the free portion to be moved against the surface by pulling the band;
• The deployment tool comprises a stent for holding the endoprosthesis in the axial direction prior to the radial deployment of the latticework, the actuation band being retained in the stent and remaining movable through the stent with respect to the endoprosthesis so as to be pulled from the distal end of the stent ;
• - The flexible intermediate member is spontaneously deformable when the deployment tool is moved from its position to be inserted into the position for release, so that it is spontaneously caused that the free part is at least partially pulled against the outer surface;
• - The flexible intermediate member has at least one elastic member connecting the free part and the outer surface, wherein the elastic member is held in an insta bilen position under tension by the deployment tool in the insertion position;
• The latticework has an inner surface defining a central blood circulation path;
• - The latticework has at least one band for actuating the intermediate member, wherein the actuating band has at least a first connection point to the intermediate member and at least a second and third connection point to the latticework, wherein the second and third connection point at an angle to each other with respect to the latticework about its axis are offset;
• The movement of the latticework of the endoprosthesis between the contracted position and the unfolded position causes the distance separating the second connection point and the third connection point to be increased, and the axial displacement of the first connection point between a position axially spaced from the second and the third connection point and a position is shifted axially closer to the second and third points, in which the first connection point is opposite to the outer surface.

The The invention will be better understood by reading the following Description given by way of example only and reference Refer to the attached drawings, in which:

1 Figure 3 is a schematic cross-sectional partial view of the first treatment device according to the invention and the deployment tool assumes the position in which the implant can be inserted into the body;

2 a representation similar 1 in which the implant is placed in position as a replacement for a defective endogenous valve;

3 a partial perspective view is the actuating bands of the implant in the treatment device of 1 and 2 shows;

4 Figure 11 is an illustration of the implant after deployment in the blood circulation conduit;

5 is a partial cross section along an axial center plane of the relevant parts of a second treatment device according to the invention;

6 a schematic cross-sectional view along the transverse plane VI-VI in 5 is;

7 is a representation similar 5 and shows a detail of a third treatment device according to the invention;

8th is a representation similar 5 and shows a fourth treatment device according to the invention;

9 is a representation similar 5 and shows a fifth treatment device according to the invention;

10 is a representation similar 5 and shows a sixth treatment device according to the invention;

11 is a representation similar 5 and shows a seventh treatment device according to the invention;

12 is a representation similar 4 and shows the seventh embodiment of the treatment device;

13 Fig. 12 is an illustration of modifications of the implant interface of the treatment device according to the invention;

14 is a representation similar 1 and shows a modification of the device of 1 ;

15 is a representation similar 1 and shows an eighth embodiment of a treatment device according to the invention;

16 is a representation similar 2 and shows the eighth embodiment of the treatment device according to the invention after the withdrawal of the expansion tool;

17 is a representation similar 4 and a ninth embodiment of the treatment device according to the invention.

In The remainder of this document refers to the terms "distal" and "proximal" the treatment device with respect to a user of the device, which is outside the patient's body.

1 to 4 show a first embodiment of a treatment device 10 according to the invention. In particular, the treatment device has been developed for the implantation of an endovalve with a tubular endoprosthesis and a valve as a replacement for an endogenous heart valve 12 , as in 2 and 4 is shown.

As can be seen from these figures, is the body's valve 12 in a blood circulation line 14 arranged on the inside by a circumferential wall 16 is limited. The body's valve 12 has a number of flaps 18 on that within the conduit 14 from a wall 16 can be moved out.

According to 1 to 4 has the device 10 an implant 20 on, that's an endovil 22 and an intermediate member which is permanently attached to the endovalve 22 is attached and a seal around the endovalve 22 around and between the endovalve 22 and the blood line 14 creates. The device 10 still has a tool 26 to unfold the Endoven tils on as well as facilities 28 for moving the intermediate member 24 through which these around the endovalve 22 is flipped down around when the implant 20 is unfolded.

As in 1 and 4 show, points the endovalve 22 a tubular endoprosthesis 30 on, which has a central blood circulation channel 32 forms, and a valve 34 or a closure associated with the endoprosthesis 30 within the channel 32 connected is.

The endoprosthesis 30 consists of an open grid construction 36 with a mesh of ribbons or filaments having elastic properties. The gridwork 36 is made by weaving at least one stainless steel filament of an alloy of a polymer having a memory effect. Alternatively, a tube can be made by laser cutting.

The gridwork 36 limits an inner circumferential surface 38 and an outer circumferential surface 40 which has substantially an X-X 'axis. The surfaces 38 and 40 are substantially cylindrical and extend along the X-X 'axis between a proximal circumferential edge 42 and a distal circumferential edge 44 near the top of the 1 ,

The gridwork 36 the endoprosthesis 30 may be between a collapsed position in which the diameter is small and an insertion into the conduit 14 allows, and a deployed position, which forms the relaxed position in which the diameter is large, unfolded. At the in 1 to 4 shown example, the lattice 36 be deployed at the same time between the contracted position and the relaxed position.

The valve 34 For example, it is made from the body's own valve of an animal, such as a pig. Alternatively, there is the possibility of preparation of natural bovine or cardiac tissue of sheep or synthetic tissue.

Conventionally, the valve includes 34 a tubular base 46 on the inner surface 38 of the latticework 36 is attached, and three flexible locking tabs 48 of the central channel 32 that are at the base 38 extend downwards.

The flaps 48 are radially movable in the direction of the X-X 'axis of the channel 38 between a blocking position in which it substantially travels a blood stream in the channel 32 completely lock, and an opening position of the channel 32 in which they are essentially flat against the inner surface 38 abut and allow the blood to pass through the canal 32 flows.

In the locked position have the flaps 48 a converging cross section towards the proximal edge 42 of the valve.

In the in 1 to 4 shown example, the intermediate member 24 a flexible wrap around apron 60 on, attached to the tubular endoprosthesis 30 attached, and an annular seal 62 on the apron 60 is appropriate.

The skirt 60 For example, it is made of a material such as Dacron or a polymer film. It has a substantially continuous, cylindrical or conical shape around the X-X 'axis. In particular, the skirt is more flexible than the latticework 36 the endoprosthesis 12 ,

The skirt 60 extends between a connection edge 64 with the endoprosthesis 30 that stuck to the latticework 36 attached, and a free edge 66 ,

The connecting edge 64 is in the central channel 32 near the distal edge 44 educated. He is on the inner surface 38 of the latticework by known means, such as glue or sewing.

As will be seen below, the skirt bounds between its connecting edge 64 and the free edge 66 a free part 68 having the length greater than 0 and axially outward to the central channel via the distal end 44 protrudes.

The skirt 60 has a length along the X-X 'axis between the connection edge 64 and the free edge 66 which is 20% larger than the length of the endoprosthesis 30 is.

At the in 1 The example shown is the annular seal 62 outside on the apron 60 along the free edge 66 appropriate. The seal 62 forms a deformable annular collar of compressible foam or the like.

According to the invention, the apron 60 and the annular seal 62 together between a configuration with minimum radial dimension within the axial extension of the endoprosthesis 30 , in the 1 and a configuration for insertion between the endoprosthesis 30 and the line 14 that face down against the outside surface 40 the endoprosthesis 30 worked, deformable.

In the configuration with minimum radial dimensions, which in 1 is shown, the apron extends 60 axially in the extension of the endoprosthesis 30 over the distal edge 44 out. In this example, the free edge lies 66 axially spaced from the distal edge 44 the endoprosthesis and at maximum distance from the distal edge 44 ,

The free part 68 and the annular seal 62 become axially projecting in this way in the extension of the outer surface 40 and axially spaced from this surface. The length of the free part 68 that from the outer surface 40 protrudes, over the edge 44 out, is maximum.

At the in 14 shown modification has the skirt 60 a free edge 66 on, partially down in the direction of the connecting edge 64 pivoted in the configuration with minimum radial dimensions. The skirt 60 limited in this way an annular fold 70 that is a maximum distance from the edge 44 having. It has an inner area 71 on that between the connecting edge 64 and the fold 70 lies, as well as an outer area 72 that goes around the inner area between the fold 70 and the free edge 66 the apron stretches.

In the minimum radial diameter configuration, the outer areas are 72 and the free edge 66 axially spaced from the distal edge 44 and away from the outer surface 40 arranged.

In the lowered position, the in 2 shown is the apron 60 down against the outer surface 40 the endoprosthesis 30 wrapped. In this configuration, the free edge 66 and the annular seal 62 opposite the outer surface 40 and arranged around it. In this example, the seal lies 62 essentially at the level of the valve 34 as it is in 4 is shown.

The free part 68 covered on the outside of the distal area of the endoprosthesis around the outer surface 40 around. The skirt forms a circumferential fold over the distal edge 44 the endoprosthesis.

In the example of 1 has the unfolding tool 26 a stent 80 on, the endo Valve 22 supports and axially holds in position within the pipe 14 , where thread-like bands 82 for holding the gridwork 36 in the contracted position against the stent 80 are provided and a protective cover 84 that the implant 20 and the stent 80 absorbs, supports inside.

The deployment tool 26 is of the kind as described in the French patent application FR-A-2 863 160 of the applicant is described.

As described in the above-mentioned application, the stent extends 80 between a proximal end, not shown, for manipulation by the surgeon outside the human body, and a distal end 88 for insertion into the pipe 40 for the valve 12 ,

At its distal end 86 is the stent with a profiled lip 88 provided so that the deployment tool 26 that the implant 20 contains, within the conduit 14 can be accommodated without damage.

As will be seen below, the tool can 26 be changed, so it is different from a configuration for inserting the implant in the line 14 in a configuration for releasing the implant 20 changed in the line.

In the configuration for insertion is the implant 20 coaxially around the stent 80 around below the lip 88 near the distal end 86 arranged. The stent 80 is therefore in the central channel 32 and through the apron 60 inserted through.

As described in the above application, the thread-like bands are 82 solvable.

They surround the gridwork 36 the endoprosthesis 30 near the distal end 44 and the proximal end 42 ,

The bands 82 can be from the proximal end of the stent 80 be pulled and released between a configuration for holding the gridwork 36 in the contracted position against the stent 80 and a configuration for releasing the gridwork 36 in which the lattice work 36 takes his extended position.

The case 84 is coaxial around the stent 80 around and the implant 20 arranged.

It has a proximal shaft 90 on and an enlarged distal head 92 with a diameter larger than the shaft 90 is and an inner cylindrical housing 94 forms for receiving the implant.

The head 92 extends between a proximal shoulder 96 with which the stem and a distal circumferential rim 98 against the top 88 is applied.

The sheath is axially movable along the axis XX 'and moves around the stent 80 around between a distal position that is in 1 is shown and in which the implant assumes the position for insertion, and an intermediate position according to 2 and a proximal withdrawal position, not shown, which is the relaxed position of the implant 20 represents.

In relation to 3 points the head 92 a cylindrical wall 100 on that near the distal edge 98 lies and three eyelets 102 forms, which are arranged at an angular distance about the axis XX '.

The eyelets 102 are in relation to the wall 100 arranged so that they are in the housing 94 open, and outside the wall 100 not the case 94 are opposite.

In the distal position, the in 1 is shown, the distal edge lies 98 the shell 84 flat against the top 88 at. The cylinder wall 100 extends according to the implant 20 , The housing 94 is through the cap 88 locked.

In the intermediate position, the in 2 is shown, is the shell 84 partially towards the proximal end of the stent 80 has been moved so that part of the implant 20 by moving away from the cap 88 is exposed. The distal edge 98 then lies opposite the proximal part of the endoprosthesis 30 ,

In the proximal position, the implant is completely exposed and the sheath 84 subtracted to the outside of the patient.

In the first embodiment of the device 10 according to the invention, the means comprise 28 for moving the intermediate member 24 thread-like, breakable drawstrings 104 ,

The drawstrings 104 are connected on the one hand with the eyelets 102 along the distal edge of the sheath 84 and on the other hand with the apron 60 along her free edge 66 ,

As in 4 is shown comprises each thread-shaped band 104 a closed loop of the band 106 and a tear-off ring 108 ,

Every loop 106 runs through the two eyelets of a pair 102 , Therefore, a part protrudes into the housing 94 in and out part out of the housing into engagement with the ring 108 ,

The ring 108 is through the fabric that the apron 60 forms, along the free edge 66 held. The band that the ring 108 forms, has a much lower tensile strength than the thread, the loop 106 forms. The ring 108 is sewn or knotted in the apron, so that when parts of the thread forming the ring are torn, with the apron 60 stay connected.

The operation of the treatment device 10 according to the invention when introducing the implant 20 in an endogenous valve will now be described.

First, the implant 20 at the deployment tool 26 appropriate. The implant is therefore coaxial with the stent 80 , The thread-like loops 82 lie around the endovalve 22 around and are pressed to unfold the fret 36 from the relaxed position of large diameter, to the contracted position of low diameter against the stent 80 ,

Furthermore, during the assembly, the apron 60 in their configuration with reduced radial dimensions spaced from the outer surface 40 the endoprosthesis arranged. The free part 68 the apron 60 and the seal 62 therefore extend around the stent 80 around between the distal edge 44 and the cap 88 , They are laid flat radially in the direction of the X-X'-axis against the stent 80 ,

The case 84 is moved to the distal position by coaxial displacement along the stent 80 brought. The loops 106 be in the eyelets 102 the shell 84 captured, and the rings 108 are captured in the fabric that the apron 60 forms.

The deployment tool 26 then takes its configuration for insertion into the line 14 one in 1 is shown in which it has minimal radial dimensions, since the intermediate member 24 from the outer surface 40 the endoprosthesis 30 Will get removed.

Next is the tool 26 into the interior of the blood circulation line 14 introduced. The stent 80 that the implant 20 wears and the shell 84 be in the direction of the valve 12 moved until the shell 84 between the layers 18 of the body's own valve 12 lies where they are removed radially.

The stent 80 is held in the axial direction and the shell 84 is partially peeled off in the middle position, so that it is the implant 20 partially uncovered. It is therefore moved proximally with respect to the stent so that the distal edge 98 from the cap 88 Will get removed.

During this shift, how out 2 shows, the thread-like bands 104 tightened. When the ribbons 104 tightened causes the proximal displacement of the shell 84 a move on the free edge 66 the apron 60 towards the proximal edge 42 the endoprosthesis.

The seal 62 and the apron 60 then go down around the outer surface 40 the endoprosthesis 30 folded down until the apron 60 takes up her postponed position.

In this configuration, cover the apron 60 and the annular seal 62 the distal part of the endoprosthesis 30 and extend up to the flaps 18 of the body's own valve.

Next, the surgeon exerts a strong proximal pull on the sheath 84 out, leaving the rupturable rings 108 be torn. The case 84 is then completely withdrawn and brought to the outside of the patient. The surgeon then loosens the thread-like ligaments 82 and stretch the gridwork 36 in the radial direction.

During this deployment, the lattice moves 36 in the deployed position and the tool then takes the configuration for removal. The outer surface 40 under the apron 60 lies against the wall 16 laid and limited the line 14 in the proximal part of the endoprosthesis 30 ,

In the distal part of the endoprosthesis, which is covered by the apron, is the intermediate member 24 arranged between the outer surface 40 the Wall 16 the line 14 or between the surface 40 and the flaps 18 , The seal 62 takes the space between the flaps 18 , and closing and sealing the pipe 14 around the endoprosthesis 30 around.

During diastole, the blood that has the tendency becomes in the lead 14 from the bottom up in 4 to flow back through the flaps 48 closed. By the way, the blood can not be around the endoprosthesis 30 flow around, as the apron 60 is present, which is towards the proximal end 42 the endoprosthesis opens, and because of the seal 32 ,

The risk of leakage through the endovalve 42 and around the endovalve is therefore significantly reduced during diastole.

The bands 82 and the stent 80 are then pulled out of the patient.

The treatment device 10 according to the Invention therefore makes possible an endoprosthesis 22 in a tight condition against the outer wall 16 the blood circulation line 14 while laying a minimum radial dimension when introducing into the pipe 14 having.

In a modified embodiment, the surgeon completely removes the cover of the implant 20 as it was described above, leaving the apron 60 is placed completely down without the bands 104 be torn.

Next, he loosens the thread-like bands 82 and unfold the prosthesis radially. When this is done and if the position is satisfactory, he can apply a strong proximal pull so that the ligaments 104 destroyed and the shell 84 is solved.

The second embodiment of the device 120 according to the invention, in 5 and 6 is different from the first embodiment 10 in the way of displacement means 28 ,

In the second embodiment of the device 120 include the funds 28 to move the endoprosthesis a single thread-shaped band 104 consisting of two bands 122 are formed, leading to a loop 104 connected at the distal end. The bands 122 have a distal retention area 125 on, one after the other and alternately through eyelets 102 and through the apron 60 along her free edge 66 is drawn. The bands 122 form a proximal control area 126 extending longitudinally through the shell 84 to the proximal end of the stent 80 extends, so that the surgeon receives the possibility of operation by train outside the patient.

Otherwise, the cylindrical wall forms 100 inside an axial circulation passage 128 extending radially in the direction of the X-X 'axis in the housing 94 through a radial return opening 129 opens.

The shifting means 28 include a pen 130 to hold the loop 124 in the channel 122 leading to the proximal end of the stent 80 extends and is actuated by the surgeon. The pencil 130 is movable between a distal retention position in which the loop 124 opposite the radial opening 129 held, and a proximal trigger position in which he is from the loop 124 and from the retaining opening 129 is deducted.

In the beginning and when the apron 60 is shifted to fold over the outer surface 40 the endoprosthesis 30 takes the pen 130 the distal position in the loop 124 one. The bands 122 that through the apron 60 are then axially with respect to the shell 84 through the eyelets 102 held. The proximal displacement of the sheath 84 thus causes a proximal displacement of the free edge 66 the apron 60 ,

If the apron 60 is completely turned down, the pin becomes 130 pulled towards its proximal position, leaving the loop 124 is released. The surgeon then pulls the control area 126 so that the holding area 125 the loop 124 from the apron 60 out and out of the eyelets 102 is pulled and can be stored outside the patient's body. The case 84 then completely from the implant 20 solved.

In the modified embodiment according to 7 extends the pin 130 only over a shorter length in a housing that is shorter than the wall 100 and in the wall 100 into it. The stylus is at its proximal end by a control band 142 that is more flexible than the pen 130 and that goes to the proximal end of the stent 80 extends, extends.

The thickness of the thread 142 is much smaller than the pen 130 , The ribbon 142 can be pulled by the surgeon to release the loop 104 from the pen 130 as described above.

The fourth embodiment 150 according to the invention, in 8th is different from the first embodiment in that the shifting means 28 out of hooks 152 exist, which is integral with the cylindrical wall 100 are formed. The hooks 152 protrude in the housing 94 from the wall 100 downward. They are, for example, integral with the wall 100 educated.

The free edge 66 the apron 60 lies between the wall 100 and each of the hooks 152 when the position with reduced radial dimensions is selected.

Folding down the apron on the surface 40 is caused by shifting the hooks 150 to the proximal end of the stent 80 while the sheath 84 moved from its distal position to the proximal position.

The fifth embodiment 160 according to the invention, in 9 is different from the first embodiment 10 in that the shifting means 28 the apron independent of that for the shell 84 are. The shifting means 28 comprise a plurality of sliding bands 162 , which are arranged at an angular distance about the axis XX 'around, and of which only one band in 9 is shown.

Each band extends between a distal end 164 that is detachable at the free edge 66 the apron 60 is attached, and a proximal end (which is not shown, and that to the outside of the stent 80 protrudes at its proximal end.

Every band 162 points from the distal end 164 a first axial region 166 on, standing outside and along the apron 60 extends and outside the outer surface 40 , to the proximal edge 142 of the latticework 36 and a second distance 168 who is in the channel 28 and inside the apron 60 to the cap runs.

Every band 164 then has a third section 170 on that in an angled holding channel 170 lies in the cap 88 located, and a fourth section 192 that goes through the stent 80 to the proximal end of the stent 80 extends.

If the surgeon at the proximal end of the band 162 pulls, becomes the distal end 164 moves, making it toward the proximal end or edge 42 the endoprosthesis 30 is pulled. This reduces the length of the first section 166 and the length of the second section 168 so that the distal end 164 closer to the proximal end 42 is pulled. The skirt 60 becomes the endoprosthesis 30 pulled down around.

The sixth embodiment 180 according to the invention, in 10 is different from the first embodiment 10 in that the intermediate member is directly movable from the configuration of reduced dimensions to the downwardly folded configuration.

The intermediate link 24 therefore has a number of elastic attachment members 182 which are axially extensible between an unstable maximum dimension position in length and a minimum length pleated position representing the rest position. Each of the fastening organs 182 is on the one hand with the outer surface 40 the endoprosthesis 30 and on the other hand with the free edge 66 the apron 60 connected.

If the implant 20 at the deployment tool 26 is attached, the fastening organs 182 brought into their unstable pull-out position and in this position through the shell 84 held. The apron assumes the position of reduced radial dimensions in this position.

If the case 84 is withdrawn and the implant 20 the attachment organs move 182 at the same time in its folded position, in the apron 60 around the outer surface 40 folded down around.

The seventh embodiment of the treatment device 190 according to the invention, in 11 and 12 is different from the first embodiment 10 in that a plurality of pontics 24 is provided which extends in angular positions about the X-X 'axis along a circumference of the outer surface 40 are distributed. Each pontic 24 has no apron and has a role 192 made of deformable foam.

Every role 192 is on the outer surface 40 at the ends at two points 194 fixed, which are arranged at an angular distance around the X-X 'axis around. Every role 192 forms between the attachment points 194 an area 196 that is free with respect to the surface 40 is displaceable. this section 196 is deformable between an unstable configuration with minimum radial dimensions according to 11 and a configuration for insertion according to FIG 12 which position represents the rest position.

In the configuration with minimum radial dimensions is a part of the section 196 axially away from the outer surface 40 over the distal edge 44 been postponed. This part is by the shell 84 kept at a distance from the surface.

If the case 84 is withdrawn, the section 196 directly deformed by changing its configuration for insertion. In this configuration, the envelope lies flat against the surface 40 along the circumference between the attachment points 194 ,

In a modified embodiment, the intermediate links in 13 shown. In the variant of the intermediate member 24 according to 13a is a circumferential skirt with an annular seal 62 provided, which consists of a deformable roller attached to the outer surface of the skirt 60 is attached when the apron 60 is in the position with minimum radial dimensions. In the variant according to 13b is the seal 62 on the inner surface of the apron 60 fastened when the apron 60 in their configuration with minimum radial dimensions.

In the embodiment according to 13c the annular seal has been formed by a fabric fold.

An eighth embodiment of the device 210 is in 15 and 16 shown. Unlike the first embodiment 10 shows the eighth embodiment 210 a non-tear threadbare loop 212 for actuating the intermediate member 24 on that the free edge 66 of the Zwi limb with the latticework 36 combines.

The thread-like loop 212 therefore has at least one operating area 214 in the form of an approach. The operating area 214 has a connection point 216 on, on the intermediate link 24 is attached, and a second and third connection point 218 . 220 attached to the latticework 36 are attached.

The first connection point 216 For example, it is fastened near the free edge, as described above. It is located between the second attachment point with respect to the X-X 'axis 218 and the third attachment point 220 ,

The thread-shaped band 212 is substantially non-extensible in the longitudinal direction and remains substantially constant in length.

When the deployment tool 26 is in the configuration for insertion is the gridwork 36 in the collapsed position, the in 15 is shown.

The length h1 of the axial section of the area 214 , along the X-X 'axis, between the first attachment point 216 and the limb 224 is maximum and is greater than the distance that the limb 224 from the distal edge 44 the endoprosthesis 30 separates. The first attachment point 216 takes a position axially spaced from the first and the second attachment point 218 . 220 one.

The skirt 60 and the annular seal 62 is located in the configuration with minimal radial dimensions and in the axial length of the endoprosthesis 30 , The first attachment point 216 is located beyond the distal edge 44 axially spaced from the endoprosthesis 30 ,

Besides, the distance is 11 , the second attachment point 218 from the third attachment point 220 separates, minimal, as well as the diameter D1 of the latticework 36 the endoprosthesis 30 is minimal.

When the deployment tool 26 from its configuration for inserting the implant 20 into the pipe 14 to the configuration for releasing the implant 20 is converted, the lattice 36 the final prosthesis 30 from the contracted position to the deployed position during disengagement of the bands 82 changed.

As in 16 is shown, the diameter D2 of the latticework increases 36 to. The second attachment point 218 then moves away from the third attachment point 220 and the distance 12 between these two points in the unfolded position of the latticework 36 is greater than the distance 11 which separates these two points in the contracted position.

This increase in the distance causes an increase in the length of the peripheral portions 226 of the operating area 214 and the corresponding reduction in the length of the axial sections 222 ,

The first attachment point 216 thus moves axially closer to the member 224 , and the plane P perpendicular to the axis X-X ', which is the second attachment point 218 and the third attachment point 220 contains until the first attachment point 216 a position axially closer to the second attachment point 218 and the third attachment point 220 occupies, in which the first attachment point 216 opposite the outer surface 40 of the latticework 36 lies.

The length h2 of the axial sections 222 between the first attachment point 216 and the limb 224 is therefore minimal.

The movement of the first attachment point 216 who is at the free edge 66 the apron 60 attached, that causes the apron 60 down against the upper surface 40 of the latticework 36 is placed in the position in which the endoprosthesis 30 into the pipe 14 can be inserted.

In general, the band 212 from a single and continuous band of different operating ranges 214 exist across the perimeter of the latticework 36 are distributed.

In a modified embodiment, the loop 212 with the apron 60 in a connection point 216 in the area of the free edge 66 connected without being attached to the apron. Similarly, the loop 212 with two limbs of the latticework 36 connected at an angular distance about the axis XX 'around, without on the latticework 36 in the area of the second and third composite points 220 . 222 to be connected to the latticework.

As in 1 shown are the valve 34 and the intermediate member 24 separate and independent from each other.

Therefore, the connecting edge is axially spaced from the valve 34 ,

Otherwise, as in 16 is shown, the maximum extent of the free edge 66 of the pontic more than the maximum circumference of the distal edge of the latticework 36 in the unfolded position.

In the modification according to 17 has the endovalve 22 an internal valve reducer 300 the more flexible the latticework is 36 so that he is in the central channel 32 can be folded when the lattice work 30 having the contracted position and in the central channel 32 can be deployed when the lattice work 36 in the unfolded position. A valve reducer of this kind is used in the FR 07 55355 described by the applicant.

This valve reducer 300 has a distal apron 302 converging cross-section towards the proximal edge 42 on, and a tubular inner wall 304 is shorter in length than the latticework 36 and smaller in diameter than the lattice work 36 , and a proximal apron 306 converges in cross section towards the distal edge 44 ,

The proximal apron 306 , the tubular inner wall 304 and the distal apron 302 preferably consist of a single piece of deformable material, such as a fabric such as Dacron, or a plastic film.

The distal apron 302 is stuck to the gridwork 36 along the distal edge 44 appropriate. It extends convergently in the direction of the proximal edge 42 as far as the inner wall 304 has a distal edge.

The proximal apron 306 is fixed to the proximal edge 42 appropriate. It extends converging towards the inner edge 44 , as far as the proximal edge of the inner wall 304 is available.

The inner wall 304 thus forms an opening 308 smaller diameter than the central channel 32 ,

The valve 34 is preferably permanent or movable at the opening 308 attached and bounded inward by the wall 304 ,

As in detail in the FR 07 55355 described are the aprons 302 and 306 and the wall 304 inside covered with a dense coating, allowing the blood through the inner opening 308 and the valve 34 and prevents the blood from entering the room, which is bounded at an angle between the aprons 302 . 306 and the latticework 36 ,

Summary

Device for treatment a blood circulation line

The device ( 10 ) comprises an implant ( 20 ) with a tubular endoprosthesis ( 30 ) within a radially deployable framework ( 36 ).

The implant ( 20 ) has a flexible intermediate member ( 24 ), which is movable on the endoprosthesis ( 30 ) is mounted so that an insertion between the outer surface ( 40 ) and a blood circulation line ( 14 ) is possible.

The device ( 10 ) comprises a deployment tool ( 26 ), which has a configuration for inserting the implant ( 20 ) and a configuration for releasing the implant ( 20 ) can take.

In the configuration for inserting the implant ( 20 ), the flexible intermediate member ( 24 ) at least one free part ( 68 axially spaced from the outer surface (FIG. 40 ), so that the radial dimension of the implant ( 20 ) is minimized. The free part ( 68 ) is at least partially against the outer surface ( 40 ) displaceable when the tool ( 26 ) is moved out of the configuration for insertion into the released configuration.

QUOTES INCLUDE IN THE DESCRIPTION

This list The documents listed by the applicant have been automated generated and is solely for better information recorded by the reader. The list is not part of the German Patent or utility model application. The DPMA takes over no liability for any errors or omissions.

Cited patent literature

• US 2005/0137688 [0010]
• FR 2863160 A [0061]
• FR 0755355 [0147, 0154]

Claims (15)

Contraption ( 10 ; 120 ; 140 ; 150 ; 160 ; 180 ; 190 ; 210 ) for the treatment of a blood circulation line ( 14 ), comprising: - an implant ( 20 ) for placement in the line ( 14 ), which implant ( 20 ) comprises: a tubular endoprosthesis ( 30 ) with an X-X 'axis, which is a latticework ( 36 ), which is radially deployable between a contracted position and an unfolded position, which gridwork ( 36 ) an outer surface ( 40 ), which by an axial edge ( 44 ) is limited; At least one intermediate link ( 24 ), which is more flexible than the gridwork ( 36 ), wherein the flexible intermediate member ( 24 ) movable on the endoprosthesis ( 30 ) for insertion between the outer surface ( 40 ) and the line ( 14 ) and • a tool ( 26 ) for deploying the implant ( 20 ), which tool has a configuration for inserting the implant ( 20 ) into the line ( 14 ), in which the tool ( 26 ) the latticework ( 36 ) holds in the collapsed position and a configuration in which the implant ( 20 ) and the gridwork ( 36 ) assumes its unfolded position, characterized in that in the configuration for insertion the flexible intermediate member ( 24 ) at least one free part ( 68 ) spaced axially from the outer surface ( 40 ) beyond the axial edge ( 44 ) is maintained to minimize the radial dimensions of the implant ( 20 ), which free part ( 68 ) at least partially against the outer surface ( 40 ) is movable when the tool ( 26 ) is switched from its configuration to paste into the detached configuration. Contraption ( 10 ; 120 ; 140 ; 150 ; 160 ; 180 ; 210 ) according to claim 1, characterized in that the intermediate member at least one flexible circumferential skirt ( 60 ) with a border ( 64 ) which is attached to the endoprosthesis ( 30 ), and a free edge ( 86 ), the apron ( 60 ) is movable between a configuration of reduced radial dimension, in which the free edge ( 66 ) axially spaced from the axial edge of the outer surface of the apron ( 60 ) in the configuration for insertion, and a configuration facing down against the outer surface of the skirt (FIG. 60 ) is folded in the release position. Contraption ( 10 ; 120 ; 140 ; 150 ; 160 ; 180 ; 210 ) according to claim 2, characterized in that the intermediate member at least one radial seal ( 62 ) which radially with respect to the skirt ( 60 ). Contraption ( 10 ; 120 ; 140 ; 150 ; 160 ) according to one of the preceding claims, characterized in that the device comprises at least one band 104 for actuating the intermediate member, wherein the or each band ( 104 ) detachable with the free part ( 68 ) of the deployment tool ( 28 ), each actuating band being axially fixed with respect to the end prosthesis ( 30 ) for pulling the free part ( 68 ) towards the outer surface ( 40 ) is movable when the deployment tool ( 26 ) is moved from its position to being inserted into the position of release. Contraption ( 10 ) according to claim 4, characterized in that the or each operating band ( 104 ) can be broken by axial tension. Contraption ( 120 ; 140 ) according to claim 4, characterized in that the or each operating band ( 104 ) a locking loop ( 124 ) that the deployment tool ( 26 ) a pin ( 130 ) that the pin ( 130 ) is movable between an engagement position in the locking loop ( 124 ), in which the axial displacement of the operating band ( 104 ) in relation to the endoprosthesis ( 30 ) the axial displacement of the free part ( 68 ) in relation to the endoprosthesis ( 30 ) and a released position from the lock loop ( 124 ), in which the axial displacement of the belt ( 104 ) a relative movement of the free part ( 68 ) causes. Contraption ( 10 ; 120 ; 140 ) according to one of claims 4 to 6, characterized in that the unfolding tool ( 26 ) a case ( 84 ) for receiving the implant ( 20 ) which is axially movable with respect to the implant ( 20 ), wherein the operating band ( 104 ) is releasably connected to the shell ( 84 ) and the movement of the envelope ( 84 ) of the endoprosthesis ( 30 ) continues a movement of the free part ( 68 ) towards the outer surface ( 40 ) by pulling on the belt ( 104 ). Contraption ( 160 ) according to one of claims 4 to 6, characterized in that the unfolding tool ( 26 ) a stent ( 80 ) for the axial fixing of the endoprosthesis ( 30 ) before the radial unfolding of the latticework ( 36 ), wherein the operating band ( 104 ) in the stent ( 80 ) and is movable with respect to the endoprosthesis ( 30 ) through the stent ( 80 ) for actuation from the proximal end of the stent ( 80 ). Contraption ( 160 ; 190 ) according to one of claims 1 to 3, characterized in that the flexible intermediate member ( 24 ) is spontaneously deformable when the deployment tool ( 26 ) is switched from its configuration for insertion into the configuration for release, so that spontaneously causes the free part ( 68 ) at least partially against the outer surface ( 40 ) is moved. Contraption ( 180 ) according to claim 9, since characterized in that the flexible intermediate member ( 24 ) at least one elastic component ( 182 ) having the free part ( 68 ) with the outer surface ( 40 ), wherein the elastic component ( 182 ) in an unstable position under tension by the deployment tool ( 26 ) is kept in the configuration for insertion. Contraption ( 10 ; 120 ; 140 ; 150 ; 160 ; 180 ; 190 ; 210 ) according to one of the preceding claims, characterized in that the latticework ( 36 ) an inner surface ( 38 ) for limiting a central blood circulation channel ( 32 ) and that the implant ( 20 ) a valve ( 34 ), which on the inner surface ( 38 ) for the selective closure of the central channel ( 32 ) is attached. Contraption ( 210 ) according to one of the preceding claims, characterized in that the device comprises at least one band ( 212 ) for actuating the intermediate member, wherein the actuating band ( 212 ) at least one attachment point ( 216 ) for connection to the intermediate member ( 24 ) and at least one second and third attachment point ( 218 ; 220 ) at angular spacing on the latticework ( 36 ) with respect to the axis XX '; the movement of the latticework ( 36 ) of the endoprosthesis ( 30 ) between the contracted position and the relaxed position causes the distance between the second and third attachment points ( 218 ; 220 ) is separated, enlarged and the axial displacement of the first connection point ( 216 ) between a position at an axial distance from the second and third connection point (FIG. 218 ; 220 ) and a position in axial closer proximity to the second and third connection points ( 218 ; 220 ), the first connection point ( 218 ) against the outer surface ( 40 ) lies. Device according to one of claims 2 to 12, characterized in that the apron ( 60 ) a free edge ( 66 ), which is partially folded down in the direction of the connecting edge ( 64 ) on the endoprosthesis in the configuration of minimum radial dimensions. Device according to one of claims 2 to 13, characterized in that the relaxation tool a stent ( 80 ) comprising the endovil ( 22 ) in the line ( 14 ) and holds in the axial direction, and that thread-like bands ( 82 ) for holding the lattice in the collapsed position against the stent ( 20 ), the bands ( 82 ) between a position for holding the gridwork ( 36 ) in the contracted position against the stent ( 80 ) and a deployed position, wherein the bands ( 82 ) to the radial extent of the latticework ( 36 ) are detachable after the apron ( 60 ) is moved from its configuration of reduced radial dimensions to a downwardly folded position. Device according to one of the preceding claims, characterized in that the implant ( 20 ) further comprises a valve reducer ( 300 ), which is more flexible than the gridwork ( 36 ) and in the central blood line ( 32 ), which valve reducer ( 300 ) a tubular inner wall ( 304 ), which the valve ( 34 ) and has a smaller diameter than the central channel, with a distal skirt ( 302 ) for connecting the gridwork ( 36 ) and a proximal apron ( 306 ) for connection to the gridwork ( 36 ) is provided.